ALOKA ARIETTA 850
Last updated
Summary
Product
ALOKA ARIETTA 850
Issue
Medical devices - Inaccurate test or measurement results
What to do
Contact the manufacturer if you require additional information
Affected products
| Affected Products | Lot or serial number | Model or catalog number |
|---|---|---|
| ALOKA ARIETTA 850 | S/N G3042822 S/N G3042825 S/N G3042826 | ALOKA ARIETTA 850 |
Issue
|
Two issues with the diagnostic ultrasound system Arietta 850 (software version V1.0.0 - V4.1.3) Used in combination with a Fujifilm (formally Hitachi) Transducer: (1) the calculation result of eroa is displayed incorrectly when measuring lvot flow, lvot and MR flow. This error also appears in the user manual. (2) The calculation result for MVA (VTI) is displayed incorrectly when measuring MV. Recall start date: 2021-10-26 |
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Obstetrics and gynaecology
Companies
FUJIFILM HEALTHCARE CORPORATION
2-1 SHINTOYOFUTA, KASHIWA-SHI
Chiba-Ken, Japan
277-0804
Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63615
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